ALUTARD SQ Wasp Initial Pack (100 SQ-U/ml, 1 000 SQ-U/ml, 10 000 SQ-U/ml and 100 000 SQ-U/ml) suspension for injection

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Vespula spp.; Vespula spp.; Vespula spp.; Vespula spp.

可用日期:

ALK-Abello A/S

ATC代码:

V01AA07

INN（国际名称）:

Vespula spp.; Vespula spp.; Vespula spp.; Vespula spp.

剂量:

100,000

药物剂型:

Suspension for injection

治疗领域:

insects

授权状态:

Marketed

授权日期:

2019-04-12

资料单张

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1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALUTARD SQ WASP 100 000 SQ-U/ML
ALUTARD SQ INITIAL PACK
(100 SQ-U/ML, 1 000 SQ-U/ML, 10 000 SQ-U/ML AND 100 000 SQ-U/ML)
SUSPENSION FOR INJECTION
ALLERGEN FROM WASP VENOM (_VESPULA SPP._)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What ALUTARD SQ Wasp is and what it is used for
2.
What you need to know before you are given SQ Wasp
3.
How to use ALUTARD SQ Wasp
4.
Possible side effects
5.
How to store ALUTARD SQ Wasp
6.
Contents of the pack and other information
1.
WHAT ALUTARD SQ WASP IS AND WHAT IT IS USED FOR
ALUTARD SQ Wasp contains allergen (the substance that cause the
allergic reaction) from wasp
venom and is used as preventive treatment for allergy against wasp
stings.
This treatment is used for patients who are known to have serious
allergic reactions to wasp stings.
The aim of the treatment is to address the underlying cause of the
allergy. It works by gradually
increasing the immune system’s tolerance to wasp venom.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ALUTARD SQ WASP
DO NOT USE ALUTARD SQ WASP
-
if you are allergic to any of the other ingredients of this medicine
(listed in section 6)
-
if you have a disease which affects the immune system
-
if you have recently had an asthma attack and/or have recently
_ _
experienced worsening of your
asthma symptoms e.g. increase in daytime symptoms, nightly wakening,
increased need for
medication and/or activity limitations
-
if you suffer from severe heart or blood vessel disease
WARNINGS AND PRECAUTION

产品特点

Health Products Regulatory Authority
15 February 2022
CRN00C7F6
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ALUTARD SQ Wasp Initial Pack (100 SQ-U/ml, 1 000 SQ-U/ml, 10 000
SQ-U/ml and 100 000 SQ-U/ml) suspension for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ALUTARD SQ Wasp contains allergen from wasp venom (_Vespula _spp.)
adsorbed to aluminium hydroxide, hydrated. The wasp
venom species included in the mixture are: _Vespula germanica, Vespula
alascensis, Vespula maculifrons, Vespula flavopilosa, _
_Vespula pensylvanica _and_ Vespula Squamosa._
The biological activity of ALUTARD SQ Wasp is related to the
concentration of the allergen and is expressed in SQ-U/ml. The
vials are distinguished by differently coloured vial numbers.
Table 1: Vial number and strength
Vial No.
(Colour code)
Strength (SQ-U/ml)
Aluminium content in adjuvant (mg/ml)
1 (Grey)
100
0.00113
2 (Green)
1000
0.0113
3 (Orange)
10 000
0.113
4 (Red)
100 000
1.13
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection.
Clear liquid with or without a precipitate. The precipitate might be
white to faintly brown or green.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Allergy immunotherapy for patients with a documented history of
generalised and/or systemic IgE-mediated allergic reactions
due to sensitisation to wasp venom (_Vespula_ spp.), confirmed by skin
prick test and/or intradermal test and/or specific IgE test.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with ALUTARD SQ Wasp should be carried out under the
supervision of a doctor experienced in specific
immunotherapy. After each injection, the patient must be observed for
at least 30 minutes.
_Posology_
The treatment is divided into two phases; an up-dosing phase and a
maintenance phase. The aim is to gradually increase the
dose until the highest tolerated maintenance dose is reached. The
highest recommended maintenance dose is 1 ml of 100 000
SQ-U/ml (vial 4). The dosing of ALUTARD SQ Wasp must alw